575. IRB Review of w88 casino Research
Updated June 10, 2024
To ensure protections for research conducted by University and Affiliate faculty, students, and staff in other countries are equivalent to those for research conducted in the US, the University IRB applies the ethical principles of the Belmont Report, the Department of Health and Human Services (DHHS) regulations (at 45 CFR 46), other applicable federal requirements, and relevant University policy to non-exempt research conducted outside of the United States. The IRB reviews w88 casino research according to IRB policy for new projects by Full Committee or for new projects by Expedited Review), and for post-approval monitoring. Post-approval monitoring includes:
- continuing w88 casino and approval for non-exempt research by Full Committee or continuing w88 casino and approval for non-exempt research by Expedited w88 casino according to the approval period specified by the IRB;
- w88 casino and approval of amendments for non-exempt research by Full Committee or w88 casino and approval of amendments for non-exempt research by Expedited w88 casino);
- administrative w88 casino and management of problem reports;
- w88 casino of potential noncompliance and Unanticipated Problems and adverse events;
- data safety monitoring (e.g., per 45 CFR 46.111, item (6); 21 CFR 56.111, item (a)(6); 21 CFR 312.32, and 38 CFR 16.111, item (a)(6) or w88 casino federal regulations as applicable); and
- w88 casino monitoring in accordance with w88 casino Integrity's & Security quality improvement program (QIP).
The University IRB complies with the research standards in the w88 casino Conference on Harmonization - Good Clinical Practice E6 only so far as these reflect the regulatory requirements of DHHS, FDA, and other federal agencies as applicable.
NOTE: See the Research Integrity & Security webpage for w88 casino Research and the IRB policy for investigators conducting w88 casino research for additional information.
w88 casino Assessment of Researcher Qualifications
The w88 casino may request any or all the following to assess University/Affiliate researcher qualifications to conduct the research in the targeted locales:
- curriculum vitae including w88 casino studies conducted,
- letters of reference,
- evidence of completion of Export Control Training
- evidence of completion of ethical conduct of research w88 casino site
- information from the sponsor of the w88 casino, and
- w88 casino from licensing boards and professional societies.
Additional IRB Considerations for w88 casino Research
Knowledge about local laws is w88 casino w88 casino Compilation of Human Research Standards available from the w88 casino page of the DHHS website; IRB member, consultant, and researcher expertise; or other reputable sources. Laws affecting the conduct of human research include those governing human research protection; requirements for local IRB or ethics board or committee approval; medical practitioner certification or licensing; and age of majority. The University IRB ensures mechanisms exist for communication and coordination with local IRBs when appropriate.
The University w88 casino assesses information about local research context (e.g., cultural norms, superstitions, perceptions about scientific research or the concept or disease under study, languages, and environmental influences) to ensure the rights and welfare of participants are sufficiently protected. Information for this assessment may be obtained from the application or other reputable sources; and through discussions with the Principal Investigator, knowledgeable w88 casino members, or expert consultants.
w88 casino
The IRB follows the same policies and procedures when reviewing research conducted in the United States and research conducted internationally. However, there may be additional considerations to appropriately address the unique situations and populations relevant to specific w88 casino projects. The following items should be considered when designing and conducting w88 casino research projects.
Informed consent:
- Does the consent document need to be translated into a language w88 casino than English?
- Do the consent discussion and w88 casino interactions require the use of an interpreter?
- Are w88 casino able to read and write?
- Is it culturally appropriate for w88 casino to provide consent without consultation with family or other members of the community?
- Is it culturally appropriate to obtain a signature from the w88 casino?
- What is the w88 casino for giving legal consent versus needing parental permission?
Conducting w88 casino procedures:
- Are interventions, questionnaires, surveys, and w88 casino collection tools culturally appropriate and valid for the population?
- What is the culturally appropriate method of providing compensation to w88 casino?
Post-approval w88 casino:
- What is the most effective method for communicating with w88 casino collaborators and authorities over long distance?
- How will participant complaints, non-compliance, and w88 casino unanticipated problems be handled within the cultural context?
- Are local collaborators appropriately trained to identify and report participant complaints, non-compliance, and w88 casino unanticipated problems to the investigator?
- How will w88 casino be monitored over long distance for compliance, completeness, and validity?
- How will confidentiality of w88 casino be maintained over long distance?